Corante

About this Author
DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

Chemistry and Drug Data: Drugbank
Emolecules
ChemSpider
Chempedia Lab
Synthetic Pages
Organic Chemistry Portal
PubChem
Not Voodoo
DailyMed
Druglib
Clinicaltrials.gov

Chemistry and Pharma Blogs:
Org Prep Daily
The Haystack
Kilomentor
A New Merck, Reviewed
Liberal Arts Chemistry
Electron Pusher
All Things Metathesis
C&E News Blogs
Chemiotics II
Chemical Space
Noel O'Blog
In Vivo Blog
Terra Sigilatta
BBSRC/Douglas Kell
ChemBark
Realizations in Biostatistics
Chemjobber
Pharmalot
ChemSpider Blog
Pharmagossip
Med-Chemist
Organic Chem - Education & Industry
Pharma Strategy Blog
No Name No Slogan
Practical Fragments
SimBioSys
The Curious Wavefunction
Natural Product Man
Fragment Literature
Chemistry World Blog
Synthetic Nature
Chemistry Blog
Synthesizing Ideas
Business|Bytes|Genes|Molecules
Eye on FDA
Chemical Forums
Depth-First
Symyx Blog
Sceptical Chymist
Lamentations on Chemistry
Computational Organic Chemistry
Mining Drugs
Henry Rzepa


Science Blogs and News:
Bad Science
The Loom
Uncertain Principles
Fierce Biotech
Blogs for Industry
Omics! Omics!
Young Female Scientist
Notional Slurry
Nobel Intent
SciTech Daily
Science Blog
FuturePundit
Aetiology
Gene Expression (I)
Gene Expression (II)
Sciencebase
Pharyngula
Adventures in Ethics and Science
Transterrestrial Musings
Slashdot Science
Cosmic Variance
Biology News Net


Medical Blogs
DB's Medical Rants
Science-Based Medicine
GruntDoc
Respectful Insolence
Diabetes Mine


Economics and Business
Marginal Revolution
The Volokh Conspiracy
Knowledge Problem


Politics / Current Events
Virginia Postrel
Instapundit
Belmont Club
Mickey Kaus


Belles Lettres
Uncouth Reflections
Arts and Letters Daily
In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« Yes, The Research Works Act Is Dead | Main | Statin Safety »

February 29, 2012

Bias in Industry-Funded Trials in Rheumatoid Arthritis?

Email This Entry

Posted by Derek

The title of this one says it all: "Association of industry funding with the outcome and quality of randomized controlled trials of drug therapy for rheumatoid arthritis". Any number of critics of the drug business will tell you what that association is: we publish the good stuff and bury the bad news, right?

Well, not so much in arthritis, apparently. The authors identified 103 recent clinical trials in the area, over half of them industry-funded. But when it came to outcomes, things were pretty much the same. Trials from the three largest classes of funding (industry, nonprofit, and "unspecified") all tended to strongly favor the tested drug, although the small number (six) of mixed-funding trials ended up with two favoring and four against. The industry-run trials tended to have more subjects, while the nonprofit ones tended to run longer. The industrial trials also tended to have a more complete description of their intent-to-treat and workflow. As you'd figure, the industrial trials tended to be on newer agents, while the others tended to investigate different combinations or treatment regimens with older ones. But the take-home is this:

No association between funding source and the study outcome was found after adjustment for the type of study drug used, number of study center, study phase, number of study subject, or journal impact factor. . .

. . .Though preponderance of data in medical literature shows that industry funding leads to higher chances of pro-industry results and conclusions, we did not find any association between the funding source and the study outcome of "published" (randomized clinical trials) of RA drug therapies.

The one worrying thing they did find was a trend towards publication bias - the industry-sponsored studies showed up less often in the literature. The authors speculate as to whether these were trials with less favorable outcomes, but didn't have enough data to say one way or another. . .

Comments (5) + TrackBacks (0) | Category: Clinical Trials | The Dark Side | The Scientific Literature


COMMENTS

1. anon on February 29, 2012 8:51 AM writes...

Duh,
isn't the whole point of running the very expensive clinical trials to prove the efficacy and safety of the drug candidate in order to provide patients with a clinical benefit. Since the someone is putting up the money for a trial, and a lot of it, a good basis for the trial must already exist. Industry or any other sponsor isn't simply rolling the dice.

Finally, failure in a trial will halt a compounds progress quickly. That means many positive trial outcomes may precede a final negative result. That translates to many papers with positive outcomes leading to only a few paper with a negative trial outcomes.

So, one would expect nothing other than the trial results to be favoring positive outcomes.

Am I missing something?

Permalink to Comment

2. PPedroso on February 29, 2012 9:14 AM writes...

@1

Yes,

you are missing that the funding origin does not influences that expected result and I think this was the aim of the work.

Permalink to Comment

3. MTK on February 29, 2012 9:38 AM writes...

Yeah, but who was the source of funding for this study of the effect of the source of funding?


Just kidding by the way. The manuscript cites a grant from the NIH's National Center for Research Resources which was eliminated late last year.

Permalink to Comment

4. Rick Wobbe on February 29, 2012 11:59 AM writes...

Looks like evidence of scientific integrity, which would be refreshing.

If I'm not mistaken, prior reports concluded that results of industry-funded trials that were published as JOURNAL ARTICLES tended to be disproportionately positive compared to what could be found among the larger number of reports in sources like ClinicalTrials.gov. If I'm right, then this report is not inconsistent with the prior observations because they're looking at different datasets: non-literature-published trial results (RCTs, ClinicalTrials.gov, etc.) vs. literature-published results (NEJM, etc.).

Permalink to Comment

5. Brad Evans on February 29, 2012 11:46 PM writes...

1) There is a worry that medical journals receive so much funding from drug ads that they are biased in what they are willing to publish. The story is that the Annals of Internal Medicine published an article critical of drug ads in 1992 and nearly went into administration because they lost drug ads and their revenue.

2) Many organizations are establishing clinical guidelines based on evidence of drug efficacy published in the medical literature. The question is: Are some studies biased and therefore unreliable? Is there evidence that unfavorable studies have been deep sixed? (You can be biased by what you're told and what you're not told)

Thanks for your post.

Permalink to Comment

POST A COMMENT




Remember Me?



EMAIL THIS ENTRY TO A FRIEND

Email this entry to:

Your email address:

Message (optional):




RELATED ENTRIES
How Not to Do It: NMR Magnets
Allergan Escapes Valeant
Vytorin Actually Works
Fatalities at DuPont
The New York TImes on Drug Discovery
How Are Things at Princeton?
Phage-Derived Catalysts
Our Most Snorted-At Papers This Month. . .